QC Technical Services Analyst II/III bei Genezen
Genezen · Lexington, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Lexington
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The individual in this role will work collaboratively with the analytical development, quality control, and quality assurance teams to support successful transfer and implementation of QC analytical methods for the testing of viral vectors and gene therapy products in support of Genezen’s services and commercial products. The role includes executing assays, training personnel, managing materials, and generating documentation in compliance with cGMP standards and regulatory guidelines. Additionally, the role contributes to critical material and method lifecycle management and documentation.
ESSENTIAL JOB FUNCTIONS
Method Technology Transfer
- Support the implementation and technology transfer of QC analytical methods, including assay execution, personnel training, procurement of materials and reagents, documentation generation, and facilitation of knowledge transfer.
- Execute Performance Qualification (PQ) activities for new equipment.
- Compile and analyze data to support tech transfer and method implementation.
- Draft and revise equipment operational SOPs and method SOPs/worksheets in accordance with cGMP.
- Receive training on new analytical methods and support assay execution during tech transfer.
- Conduct QC Operations training for new methods and equipment.
- Manage Bill of Materials (BOM) creation and coordinate procurement for tech transfer activities.
Critical Material Management
- Lead inventory maintenance of critical materials, including freezer mapping and QC handoffs.
- Support lifecycle management of critical materials, including qualification/re-qualification and COA review and generation.
- Assist with data trending and compilation of trend reports.
Method Life Cycle and Documentation
- Support drafting of protocols and reports for QC method transfer, qualification, verification, and validation.
- Review, revise, and maintain procedures, including protocols and technical reports.
- Assist in lifecycle maintenance of laboratory procedures and SOP updates.
- Support QMS related activities by generating documentation to support change controls/deviations/investigations in eDMS systems.
- Assist in assay troubleshooting and support continuous improvement initiatives.
SPECIAL JOB REQUIREMENTS
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES | Essential/Desired |
BS or higher degree in Biology, Biochemistry, Molecular Biology or related Life Sciences | Essential |
ON-THE-JOB EXPERIENCE |
|
5+ years of relevant industry experience in QC | Essential |
| 2+ years of relevant experience with gene Therapy/Viral vector production | Desired |
SKILLS / ABILITIES |
|
Experience with laboratory techniques (qPCR, ddPCR, ELISA, cell based assays etc.) | Desired |
Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.) | Essential |
Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential | Essential |
Ability to work in a fast-paced, collaborative environment, and able to manage workload based on changing priorities | Desired |
Experience with technical writing skills such as protocol, reports, procedures etc. | Desired |
Good/effective communication and organizational skills with the ability to work well with others and independently | Essential |
Ability to work collaboratively with cross functional departments | Essential |
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
- Regularly sit for long periods of time
Movement
- Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 25 pounds
Vision
- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
